OMNILUX PLUS— 510(k) K043317

Substantially Equivalent

Photo Therapeutics Limited

FDA 510(k) clearance K043317 for OMNILUX PLUS, Substantially Equivalent on 2005-03-15. Applicant: Photo Therapeutics Limited.

Clearance details

Applicant: Photo Therapeutics Limited
Product code: Code ILY
Advisory panel: Physical Medicine
Date received: 2004-12-02
Decision date: 2005-03-15
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Altrincham, Cheshire, GB

Download summary PDF View on FDA.gov ↗

Adverse events under product code ILY

product code ILY

Death: 3
Total: 3

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Data sourced from openFDA. This site is unofficial and independent of the FDA.